Assessing the Quality of Va Human Research Protection Programs: V Vs. Affiliated University Institutional Review Board

2013 ◽  
Vol 8 (2) ◽  
pp. 153-160 ◽  
Author(s):  
Min-Fu Tsan ◽  
Yen Nguyen ◽  
Robert Brooks
Keyword(s):  
Institutional Review Board ◽  
Human Research ◽  
Institutional Review ◽  
Human Research Protection

scholarly journals The Association for the Accreditation of Human Research Protection Programs: 15 years of emphasizing research safety, ethics, and quality

2016 ◽  
Vol 2 (1) ◽  
pp. 38 ◽  
Author(s):  
Elyse I. Summers
Keyword(s):  
Institutional Review Board ◽  
Research Staff ◽  
Human Research ◽  
Research Participants ◽  
High Profile ◽  
Institutional Review ◽  
Policies And Procedures ◽  
15Th Anniversary ◽  
Research Protections ◽  
Human Research Protection

This year marks the 15th anniversary of the founding of the Association for the Accreditation of Human Research Protection Programs (AAHRPP), an organization that has been instrumental in strengthening protections for research participants. AAHRPP was established by seven Founding Members in response to a series of high-profile incidents that shook the foundation of the U.S. research enterprise. The Founding Members viewed voluntary accreditation as one way to strengthen research protections and restore and preserve public trust. Today, AAHRPP accreditation is widely regarded as the gold standard for research protections. To attain accreditation, organizations must demonstrate that they adhere to rigorous standards covering three domains: The Organization, The Institutional Review Board or Ethics Committee, and Researcher and Research Staff. The emphasis is on system-wide policies and procedures that strengthen an organization’s commitment to participants and help ensure a more consistent, more effective approach to protecting them. Because AARHPP accreditation is considered an objective indicator of quality, the benefits to accredited organizations can be considerable. Their accreditation status sends a signal — to potential research partners, to sponsors and other funders, and to research participants — that the organization has the systems in place to conduct research in a scientifically and ethically sound manner.

scholarly journals Developing Quality and Efficiency of Institutional Review Board Review Under a Human Research Protection Program at a Leading Hospital in Central Southern China: A Descriptive Analysis of the First Three Years

2021 ◽  
pp. 155626462199565
Author(s):  
Xiaomin Wang ◽  
Jessica Hahne ◽  
Lun Li ◽  
Kaveh Khoshnood ◽  
Guoping Yang ◽  
...  
Keyword(s):  
Conflicts Of Interest ◽  
Southern China ◽  
Descriptive Analysis ◽  
Institutional Review Board ◽  
Serious Adverse Events ◽  
Human Research ◽  
Institutional Review ◽  
Institutional Review Board Review ◽  
Human Research Protection Program ◽  
Human Research Protection

This study analyzes the Institutional Review Board (IRB) quality and efficiency at a leading hospital in Central Southern China, under the first three years of a Human Research Protection Program (HRPP). We conducted a descriptive, retrospective analysis from 2015 through 2017. We extracted characteristics from the protocol archive in duplicate. Of 396 protocols submitted, 98% were approved. Mean protocol review time decreased from 23 to 15 calendar days, 344 serious adverse events SAEs were reviewed, and 93 conflicts of interest (COIs) were disclosed. IRB quality and efficiency mechanisms improved. Remaining needs include increased monitoring of COIs and unanticipated problem involving risks to subjects or others, distinctions between research types, and cooperation with specialized committees.

Rethinking Local Institutional Review Board (IRB) Review at State Health Departments: Implications for a Consolidated, Independent Public Health IRB

2012 ◽  
Vol 40 (4) ◽  
pp. 997-1007 ◽  
Author(s):  
David Perlman
Keyword(s):  
Public Health ◽  
Human Subjects ◽  
Public Health Practice ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Human Research ◽  
Institutional Review ◽  
Or Practice ◽  
Human Research Protection Program ◽  
Human Research Protection

A number of unique problems plague human research protection efforts at United States (US) State and Territorial Departments of Health (DOHs). The first problem is related to the number of Institutional Review Boards (IRBs) operated by and Federalwide Assurances (FWAs) held by DOHs. The lack of these two essential regulatory human research protection program mechanisms points to a possible inadequacy of infrastructure at DOHs for protecting human subjects. The second and third problems are related to the use and interpretation of research protection laws and regulations at DOHs. Parsing public health activities into research or practice (1) can be vexing and (2) likely produces variability in (a) how individual DOHs make the determination between research and practice and (b) the outcomes of such decisions for the same or similar projects. A related problem is that DOH or Institutional Review Board (IRB) officials might misclassify public health practice activities as research (and vice versa), which can have costly, adverse consequences.

When patients decide to stop chemotherapy and choose symptom-focused care: Patients’ perspective and concerns.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 28-28
Author(s):  
Ilona Fridman ◽  
Tanya Nikolova ◽  
Paul A. Glare ◽  
E. Tory Higgins
Keyword(s):  
Quality Of Life ◽  
Preliminary Analysis ◽  
Institutional Review Board ◽  
Cancer Center ◽  
Decision Making Process ◽  
Structured Interviews ◽  
Communication Techniques ◽  
Institutional Review ◽  
Patients Perspective

28 Background: Patients often continue chemotherapy at the end of life, decreasing their quality of life without prolonging survival. Because humans tend to make emotional choices rather than rational ones when considering unpleasant options, patients are likely to reject hospice and other forms of symptom-focused care (SFC) when it could be beneficial for them. We explored patients’ perspectives on how they choose between continuing cancer treatment and SFC. Methods: Semi-structured interviews with 20 patients recruited from palliative care clinics at Memorial Sloan Kettering Cancer Center (MSKCC). Interviews covered patients’ decision-making process regarding further chemotherapy vs. SFC. Interviewees gave verbal consent, the MSKCC Institutional Review Board granting a waiver. Results: Two key conditions were identified as necessary for patients to choose SFC. First, the patient accepts that further chemotherapy is not going to be beneficial to them. Second, the oncologist endorses the transition to SFC. Preliminary analysis of treatment choices at the time of interview (see Table) also found many of those who expected they would benefit from further treatment experienced negative emotions when SFC was recommended. Conclusions: These data confirm the importance of raising prognostic awareness, and endorsing hospice. Further research should focus on developing communication techniques to recommend SFC in a way that helps patients who continue to want more treatment to calmly understand and consider carefully the advice being offered, rather than simply disliking it and quickly rejecting it. [Table: see text]

Backtalk: Ensuring school safety drills meet ethical standards

2020 ◽  
Vol 101 (8) ◽  
pp. 72-72
Author(s):  
David P. Perrodin
Keyword(s):  
School Safety ◽  
School Leaders ◽  
Institutional Review Board ◽  
Ethical Standards ◽  
Human Research ◽  
Emergency Managers ◽  
Institutional Review ◽  
The World

Schools have adopted a wide variety of procedures for their safety drills, some of them potentially traumatizing without being effective. David P. Perrodin urges school leaders to look to the world of human research for a model of how to ensure their safety drills are helpful and not harmful. An institutional review board made up of educators, emergency managers, parents, students, and other stakeholders could review any proposed safety drill procedures to ensure they are likely to achieve their purpose without inflicting unnecessary trauma.

Variations in Institutional Review Board Decisions for HIV Quality of Care Studies: A Potential Source of Study Bias

2001 ◽  
Vol 26 (4) ◽  
pp. 390-391 ◽  
Author(s):  
Charles L. Bennett ◽  
Alison M. Sipler ◽  
Jorge P. Parada ◽  
Matthew B. Goetz ◽  
Jack A. DeHovitz ◽  
...  
Keyword(s):  
Quality Of Care ◽  
Institutional Review Board ◽  
Potential Source ◽  
Institutional Review ◽  
Study Bias

Variations in Institutional Review Board Decisions for HIV Quality of Care Studies: A Potential Source of Study Bias

2001 ◽  
Vol 26 (4) ◽  
pp. 390-391 ◽  
Author(s):  
Charles L. Bennett ◽  
Alison M. Sipler ◽  
Jorge P. Parada ◽  
Matthew B. Goetz ◽  
Jack A. DeHovitz ◽  
...  
Keyword(s):  
Quality Of Care ◽  
Institutional Review Board ◽  
Potential Source ◽  
Institutional Review ◽  
Study Bias
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